Clinical trial shows strong results for Novartis’ cancer drug

Published 02/06/2025, 07:54
© Reuters.

Investing.com -- Novartis (SIX:NOVN) on Monday said that its cancer drug Pluvicto showed positive results in a late-stage trial for patients with an earlier form of advanced prostate cancer.

The drug helped slow the spread of the disease when added to standard hormone treatment.

The trial, called PSMAddition, involved patients with metastatic hormone-sensitive prostate cancer (mHSPC) whose tumors tested positive for a protein called PSMA. 

The study compared patients who received Pluvicto along with hormone therapy to those who received hormone therapy alone. 

Pluvicto helped delay the cancer’s growth in a clear and meaningful way, meeting the main goal of the trial.

Pluvicto is a targeted therapy that delivers a controlled dose of radiation directly to cancer cells. It binds to cells that express the PSMA protein, a marker commonly found in prostate cancer, and emits radiation that damages or destroys those cells. 

The drug is already approved for treating metastatic castration-resistant prostate cancer (mCRPC), and this trial evaluated its use in an earlier stage of the disease.

“These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy,” said Shreeram Aradhye, M.D., President, Development and Chief Medical (TASE:BLWV) Officer at Novartis. “These data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients”

The trial also showed a possible improvement in overall survival, which means patients may live longer with the drug, though those results are still being studied.

Prostate cancer that spreads and no longer responds to hormone treatment is hard to manage, and most patients with mHSPC eventually reach that stage. 

Novartis said there is a clear need for treatments that work in new ways and can delay this progression.

This is the third major trial where Pluvicto has shown strong results. The company recently gained U.S. approval to use the drug in an earlier stage of advanced prostate cancer based on a previous study, and now plans to submit the latest results to health regulators later this year.

The company is also testing Pluvicto in other types of prostate cancer and is expanding its use of radioligand therapy, the type of treatment used in Pluvicto, to other cancers such as breast, lung and colon. 

To meet rising demand, Novartis is increasing production at facilities in the U.S. and Europe.

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